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BREAKING: EBA finds plants produced by essentially biological processes are NOT patentable (G3/19)

The Enlarged Board of Appeal (EBA) today issued their opinion in the controversial referral G3/19 (Pepper). The full text of the opinion can be read here. Contrary to what many predicted, the EBA not only found the referral admissible, but also changed their previous interpretation of Article 53(b) EPC to being that plants and animal products produced by essentially biological processes are not patentable.

G3/19 relates to a referral to the EBA by the President following the Board of Appeal decision in T 1063/18 (Pepper). In T 1063/18 (Pepper) the Board of Appeal found that Rule 28(2) EPC (amended by the Administrative Council (AC)) was in conflict with the prior interpretation of Article 53(b) EPC by the EBA in G 2/12 and G 2/13 (Broccoli/Tomato). The Board of Appeal in T 1063/18 (Pepper) thus found that the AC Rule amendment was void. The Board of Appeal also did not feel it necessary to refer the issue to the EBA, reasoning that the EBA had already decided on the question in G 2/12 (Broccoli/Tomato II). The President subsequently referred the question of the patentability of plants produced by essential biological processes to the EBA following a meeting of the AC.

Hopes for the patentability of natural plant products wither

The EBA found the referral from the President to be admissible. The EBA further endorsed the interpretation that Article 53(b) EPC in combination with Rule 28(2) EPC excludes animals and plants produced by essentially biological processes from patentability. The EBA opinion appears at odds with their previous opinions in G2/12 and G2/13. How can the EBA change its mind on such a key aspect of EPC interpretation? The EPO press release explains:"On the merits of the referral, the Enlarged Board endorsed its earlier findings on the scope of Article 53(b) EPC, which were based on the classical (i.e. the grammatical, systematic, teleological and historical) methods of interpretation. However, the Enlarged Board found that a particular interpretation which has been given to a legal provision can never be taken as carved in stone, because the meaning of the provision may change or evolve over time. This meant that decisions G 2/12 and G 2/13 did not settle the meaning of Article 53(b) EPC once and for all.Taking account of the Administrative Council's decision to introduce Rule 28(2) EPC, the preparatory work on this provision and the circumstances of its adoption, as well as legislative developments in the EPC contracting states, the Enlarged Board concluded that new Rule 28(2) EPC allowed and indeed called for a dynamic interpretation of Article 53(b) EPC."Today's opinion from the EBA will come as a surprise to many patent practitioners. Many (including this Kat), had predicted that the EBA would find the appeal inadmissible - citing the lack of divergent case law to justify the referral [Merpel: Today's EBA opinion thus raises again the question of whether the EBA is truly independent and able to withstand pressure from the President and AC]. The EBA's full-reasoning will require careful reading. However, regardless of the reasons behind it, today's opinion will undoubtedly come as a blow to the European Agritech industry and the owners of the many patent applications stayed during prosecution pending the outcome of the referral. None-the-less, today's opinion will importantly not have a retroactive effect on patents filed before Rule 28(2) EPC came into effect (1 July 2017). IPKat is still digesting the opinion and will be back with more commentary in the coming days.Further Reading:
The President's Referral: Pepper gets spicy: The EPO President's Referral to the EBABoard of Appeal decision T 1063/18: BREAKING: TBA decides that Rule 28(2) EPC, excluding plant products produced by essentially biological processes from patentability, is void

12 comments:

Note that the referral was only deemed to be admissible after the Enlarged Board itself rewrote the questions to make them admissible. This seems highly irregular.

Note also the following rather astonishing findings:

at II.5: "the scenario presented in the first question would, if followed to its logical conclusion, effectively give the Administrative Council, as the authority empowered by the EPC to adopt the Implementing Regulations, a “carte blanche” to deviate from established case law and give a particular meaning to any Article of the EPC by means of the Rules of the Implementing Regulations. This would open the door to the possibility of circumventing the statutory procedures for amending the Convention itself, namely by way of a diplomatic conference pursuant to Article 172 EPC or by unanimous vote in the Administrative Council pursuant to Articles 33(1)(b) and 35(3) EPC."

and at II.6:"Question 2 already contains, in thinly disguised form, the answer that it seeks".

Thus, it seems that despite these formal deficiencies in the President's original questions, which both (a) told the EBoA the answer that it "should" give; and (b) had potentially far-reaching implications allowing the AC and President to circumvent the EPC, the EBoA nevertheless did not throw out the case, but rather *rewrote the President's questions for him* in order to find them admissible and give him (most of) the answer that he wanted.

Merpel seems quite right in these circumstances to doubt whether the EBoA is truly able to stand up to an overweening President and craven Administrative Council...

At the end of the day the Enlarged Board must take into account the changing intentions of the national states and EU and real policy considerations behind a prohibition. There is no reason to allow patenting of the products of essentially biological processes apart from legalistic analysis of the EPC. The EU and national governments have not taken this position, and so the Enlarged Board must be accepting of this reality.

The problem with this argument is there is an established way of changing the law and that is by changing the articles of the EPC. If it is truly the intent of the relevant states, then doing it that way shouldn't be so hard should it?

Case law evolves and that is what is happening, and diplomatic conferences to change the EPC happen only every 30 years or so. This way is easier, and realistically the only way to do as a practical reality. I don't see the national states objecting in any way, and let's be honest the situation of having the process prohibited and the product of the process allowable was very unsatisfactory

I agree with Devil's Advocate. The ultimate outcome is identical (in the sense of no retroactive effect) to what would have happened if the Biotech Directive or Article 53(b) EPC had instead been amended. So what, after all that, was the point of avoiding the straightforward option and instead pressing ahead with a course of action that now raises serious questions about the (lack of) independence of the EBA?

Sadly, that is not the only way in which this decision is likely to inflict long-term damage on the EPO. For example, there is also the fact that Article 164(2) EPC has been rendered otiose, as it is IMPOSSIBLE for any conflict to arise between an Article and an Implementing Regulation if the Boards adopt a "dynamic" interpretation of the Article that is based upon the "legislator's intent" as reflected in the Implementing Regulation. A sad day indeed for the rule of law.

Here is something I don't understand. The EBOA disapproved of the questions in the form that the President set out, because the logical conclusion was that it would allow the President to circumvent the EPC by amending the Rules to "give a particular meaning to any Article of the EPC".

One can say goodbye to the independence of the EBA, and hence to that of the BA. The EBA played the game wanted by the administrative council and the president.

I cannot imagine the CJEU rewriting a prejudicial question referred to it in order to give a politically correct reply wished by the commission or a member state.

I always thought that a court cannot decide ultra petita, but that is exactly what the EBA did.

That laws may be amended with time in order to bring it in line with evolving societal criteria is not at stake. That the interpretation of the EPC by the EBA might not have been the best one in its decision about broccoli and tomatoes, is one thing. At the time it was accepted. But to behave as the EBA did now is flabbergasting.

The only clean way to deal with the problem raised was an amendment of Art 53, b). So rather than do what would have been legally necessary, the EBA is now accomplice of those wanting to amend the EPC without using the proper mechanism. Was the fear of its members not being reappointed so great that the EBA gave in? I can see such changes also being adopted for other fundamental aspects. At least the members of the EBA ruling in G 3/08 had the guts to resist the then president.

When will a conference of ministers in charge of IP as provided in Art 4a EPC2000 be summoned? This could have been a perfect topic for such a conference. That the previous president did not like it, and the new one even so, is not a compelling reason. But for this the tail should not be wagging the dog.

I see the merits of all the above comments, but would just like to add that the Enlarged Board should not be seen as simply subservient to a 'conference of ministers'. Its power and usefulness comes about by being able to generate new law based on its expertise. The more we allow it to operate 'independently' the more it can attune itself to the need of the time. No one has spelled out in the comments the advantages of dynamic interpretation which justified the change in position. Surely this is a good thing when done by those that know most about patents, i.e. the Enlarged Board? Putting aside the complexities of the present case, surely a dynamic interpretation is best suited to our rapidly changing times?

Also, did anyone think about how Rule 28(2) is supposed to work in practice?

The method of making a product (a plant) is now decisive for the patentability of that product, while at the same time this method of making the product has no direct impact on the features of the product.

A plant is patentable if the causal mutation was induced. The same plant is not patentable if the causal mutation was “merely” identified in an existing plant. In the latter case, the causal mutation could still originally have been the result of induced mutagenesis, since untargeted mutagenesis techniques have been common in plant breeding for decades and have induced countless background mutations.

Just to give a practical example: say I have identified a new and inventive trait in an existing plant. This plant is not patentable under Rule 28(2). I identify the causal mutation and file a patent application claiming the same plant and provide an enabling disclosure to obtain said plant by induced mutagenesis. Now, exactly the same plant claim is patentable under the EPC. There is no obligation to disclose how a given trait was originally obtained (provided that the plant is not regulated as a GMO). There is only an obligation to provide an enabling disclosure. The disclosure requirement is met by describing the mutagenesis method. The knowledge that a native trait exists which has the same effect as the man-made trait can be kept secret without further ado.

The blessing of Rule 28(2) by the Enlarged Board is a bad joke, which will only lead to creative patent drafting and subsequent outcries by NGOs that the agrochemical industry is still patenting plants that should not be patentable (“because there should be no patents on life”).

A requirement to disclaim plants exclusively obtained by an essentially biological method does not remove the fundamental flaws in Rule 28(2). A claim directed to a plant “with the proviso that the plant is not exclusively obtained by means of an essentially biological process” only disclaims plant that do not comprise any induced mutations. Who can realistically argue that a given domesticated plant does not comprise any induced mutations? (I refer to the decades-long use of untargeted mutagenesis techniques in plant breeding.)

And what about patent infringement? An assumed infringer can (and will) state to his or her defense that he/she did not use induced mutagenesis. He/she simply crossed plants (most likely obtained from the patent holder) and obtained a new plant variety exclusively by using an essentially biological method. It is simply not possible to determine whether a given mutation was originally induced or occurred spontaneously. Would this scenario be confirmed in infringement proceedings, all plant patents have become worthless even if the patented trait has been obtained by technical mutagenesis techniques like gene editing. I sometimes believe that this scenario is exactly the objective of certain supporters of Rule 28(2) since they truly believe that patents in general and particularly plant patents are bad for society.

Plant breeding has developed from an unreproducible process of chance to a technical process that is reproducible, and which can be described in such way that it can be reworked by a person skilled in the art. The proper IP right to protect technical processes and the products obtained by technical processes are patents. I do not see any valid reason why (bio)technology in plant breeding should be regarded differently than, let’s say, in medicine. Despite the fact that the development of plant breeding into a biotechnology process is regarded undesirable by many, this can neither be negated nor reversed. Certainly not by the implementation of Rule 28(2).

The role of the EBA is by no means “to generate new law based on its expertise”. This is the role of the legislator in a system in which there is separation of powers.

According to Art 22(1, a and b) the EBA’s role lies in deciding on points of law referred to it by Boards of Appeal, or in giving opinions on points of law referred to it by the President of the EPO.

The president of the EPO is the executive, and the AC is the legislative as far as the Rules of Implementation of the EPC is concerned. In order to amend the EPC it needs a diplomatic conference.

What is at stake here is the fact that the only way to deal with the problem created by R 28(2) was to amend the EPC by calling a diplomatic conference. That the AC and the president are manifestly not keen to call a diplomatic conference is not a reason for the president to twist the arm of the EBA with the support of the AC.

A judicial body is not there to “attune itself to the need of the time”. A “dynamic interpretation is [certainly not] best suited to our rapidly changing times”, as it introduces legal uncertainty. That the law reflects society and its evolution is not a problem, but here the EBA has bowed to the pressure of both the president and the AC.

If there had been a decision of the CJEU, or even a motion adopted by the European Parliament, one could at a pinch have tolerated that the BA amends its case law, but here it is the result of a wish of the Commission which has no competence as such to dictate to any court what interpretation should be given to a law which is not only common to EU contracting states, but also to non-EU member states.

If tomorrow the UPC, should it ever come to life, issues decisions which are contrary to those of the EBA, will the latter have to adapt its position by using a “dynamic interpretation of its own case law”. I hope not, but the subservient attitude of the EBA in the present matter has created a dangerous precedent.

I would not put it past some applicants in the field, to make an attempt to bring one or more contracting states before an international arbitration chamber, as they can claim that all the investments they made in the field were in vain and cannot be recouped as patent protection is denied. May be one will even be daring to cite the EPO before such an arbitration chamber.

Dynamite and dynamic are very close. Let’s hope that the whole situation it has created will not backfire on the EBA.

You are manifestly a specialist in the domain. Your comment leads to further points.

In view of your explanations, I wonder whether R 28(2) is at all compatible with the TRIPPS agreement.

As a whole lot of patents have become worthless, citing contracting states or even the EPO before an international arbitration chamber has become even more likely.

Should tomorrow the European parliament decide that any patents on CII are to be proscribed, not just merely purely software patents as it did previously, can one expect that, should the European Commission and the AC endorse this position, the president will again put a question to the EBA in order for it to “dynamically” adapt its interpretation of Art 52(2, b and c)?

I would say the lobby to be faced then is probably much stronger than the one presently having acted in order to bring in R 28(2).

The anonymous of Monday and the reply by Attentive Observer raise a number of fundamental points. Such fundamental points not only occur with the EPC and its interpretation but also with other patent laws in which e.g. an exception to the patentability of naturally occurring products is laid down. In analogy with the argument provided by Anonymous the following could be argued in those cases. Imagine that a naturally occurring organism harbours protein A. Because of its natural occurrence protein A is then rendered unpatentable. If, however, I change a few amino acids of protein A by using conventional chemistry, I may be able to obtain a protein with improved properties (e.g. an increased effect, a longer shelf life, etc.). Because of these chemical modifications I have ended up with a protein molecule that would be patentable. Unless it appears that such a mutation would also be occurring in nature (e.g. in a closely related naturally occurring organism). Hence, also in this case, it is not the product itself, but the way it is obtained which governs the patentability (or, if you prefer, the patent eligibility). Now, the possibility to exclude naturally occurring compounds from patentability has been discussed during the negotiations coming to the TRIPS agreement. Especially the developing countries lobbied for such an exclusion and in 1990 they opted for a text of Art. 27 TRIPS to be: 'Parties may exclude from patentability:....Plants and animals, including microorganisms, and parts thereof and processes for their production. As regards biotechnological inventions, further limitations should be allowed under national law. [Document IP/C/W/383 WIPO (Documents of the Council for TRIPS with respect to the review of the provisions of Article 27.3(B), the relationship between TRIPS and the Convention on Biological Diversity and the protection of traditional knowledge and folklore].This text, which would allow national laws to exclude biotechnological inventions, such as inventions relating to DNA, proteins and living organism, from patentability was disapproved in favour of the current wording of Art. 27.3(B), which is identical to Art. 53(b) EPC.Thus, from a legal perspective - apparently - there is an approval for the patentability of products in all fields of technology (Art. 27(1) TRIPS) and also for products obtained by a process which process itself would not be fit for patent protection. This seems to be the consequence of allowing patent protection for products. Where the TRIPS agreement forced developing countries to adapt to this when joining the WTO, it now seems that some of the developed countries - for whatever reasons - seem to slip away from the general principle provided by the TRIPS agreement.

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